Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels

University of British Columbia

Status

Completed

Conditions

HIV Infections

Atherosclerosis

Treatments

Drug: Placebo

Drug: Rosiglitazone maleate

Study type

Interventional

Funder types

Other

Identifiers

NCT00143624

CTN 178

P02-0086

Details and patient eligibility

About

This trial will study the effect of rosiglitazone on the progression of atherosclerosis (hardening of blood vessels) through improvements of the sugar and fat metabolism (body buildup, breakdown and excretion of sugar and fat).

Participants will be randomly assigned to one of two groups: the first group will receive 8 mg of the study drug and the second group will be given a placebo, though neither group will know which formulation they are receiving. The study will follow both groups for one year, during which it will measure changes in blood vessel composition and activity, sugar metabolism, concentration of blood fat, and body fat distribution. This single-site study aims to enroll 50 participants.

Enrollment

50 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

HIV-positive
Between 30 and 70 years of age
Elevated blood levels of fat
On two or more anti-HIV drugs for at least12 months in a row and unlikely to change anti-HIV therapy during the study
On stable regimen for at least 6 months for women taking oral contraceptive agents or hormone replacement
On a stable regimen for at least 6 months for men on testosterone replacement
If taking nevirapine, on therapy for at least 3 months with stable liver function tests

Exclusion criteria

Pregnancy and breastfeeding
Poorly controlled diabetes
Uncontrolled hypertension or clinical evidence of heart failure
Any serious medical conditions, including an active AIDS-defining condition, pancreatitis, or hepatitis within 6 months prior to the study
Laboratory abnormalities (see investigator)
On lipid lowering agents, insulin, anabolic steroids (except for testosterone at replacement doses), oral corticosteroids at greater than replacement doses, or growth hormones
History of liver reaction or severe edema associated with current thiazolidinedione
History of hypersensitivity to thiazolidinedione